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Endotoxin testing milestone reached with European Pharmacopoeia’s animal shift
The quality control (QC) standards publication sets animal-free bacterial endotoxins testing (BET) as the new norm in Europe.
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Chemotherapy-free combination shows potential in lymphocytic leukaemia trial
Imbruvica® (ibrutinib) plus Venclexta®/Venclyxto® (venetoclax) resulted in 95 percent of chronic lymphocytic leukaemia patients surviving without disease progression for two years.
Tremfya® improves psoriatic arthritis joint function and skin clearance
Over 50 percent of psoriatic arthritis patients treated with Tremfya® (guselkumab) achieved ≥20 percent improvement in joint symptoms and complete skin clearance at one year.
Pharma supply companies form the Alliance to Zero
The Alliance to Zero was founded by eight pharma/biotech supply companies to promote the transition of the pharma sector to net zero emissions.
Tislelizumab reduces risk of death by 30 percent in oesophageal cancer trial
In a Phase III trial, Novartis’ investigational checkpoint inhibitor tislelizumab improved overall survival in patients with oesophageal squamous cell carcinoma.
EU regulators release medicine demand forecasting guidance for future crises
The new recommendations, developed in the context of the COVID-19 pandemic, are designed to help countries and other stakeholders forecast demand of medicines in future pandemics.
Lynparza® improves invasive disease-free survival in high-risk early breast cancer trial
In the Phase III OlympiA trial, Lynparza® (olaparib) reduced the risk of cancer recurrences or death by 42 percent in patients with BRCA-mutated high-risk early breast cancer.
100 Days Mission: “landmark collaboration” to protect people against future pandemics
Governments and life science leaders agree to work towards slashing the time to develop and deploy interventions and diagnostics for future pandemic threats to 100 days.
US begins testing mixed COVID-19 vaccine regimens
A Phase I/II trial will enrol 150 individuals already vaccinated against COVID-19 with one vaccine and assess the safety and immunogenicity of a booster dose of a different COVID-19 vaccine.
Risankizumab induces deep remissions in Crohn’s disease trial
Phase III trial data shows more than half of patients with moderate to severe Crohn's disease treated with risankizumab (Skyrizi®) 360mg achieved clinical remission in a year.
COVID-19 Vaccine Moderna update
Here EPR summarises the latest news from Moderna on the licensure, supply and distribution of its mRNA COVID-19 vaccine.
Cosentyx® reduces risk of juvenile idiopathic arthritis flares by 72 percent
Data from the Phase III JUNIPERA trial shows more patients with juvenile idiopathic arthritis achieved and maintained improvements in joint symptoms with Cosentyx® (secukinumab).
First-in-human universal flu vaccine trial begins
The US National Institutes of Health have begun a first-in-human trial to assess the safety and immunogenicity of a potential universal influenza vaccine candidate, FluMos-v1.
Cilta-cel induces deep and durable responses in relapsed or refractory multiple myeloma trial
New trial data shows 98 percent of heavily pre-treated relapsed/refractory multiple myeloma patients responded to Janssen’s ciltacabtagene autoleucel (cilta-cel).
WHO lists the Sinovac-CoronaVac COVID-19 vaccine emergency use
The WHO Emergency Use Listing means Sinovac’s COVID-19 vaccine is now eligible for distribution under COVAX.
Novel automated production technique could revolutionise production of small molecules
The new automated active pharmaceutical ingredient production technique, solid phase synthesis-flow (SPS-flow), enables push-button automated multi-step synthesis of small molecules.
